Navigation Links
United States Files Complaint Against Forest Laboratories for Allegedly Violating the False Claims Act
Date:2/25/2009

Pharmaceutical Company Allegedly Marketed Drugs

for Unapproved Pediatric Use and Paid Kickbacks

WASHINGTON, Feb. 25 /PRNewswire-USNewswire/ -- A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.

Acting Assistant Attorney General Michael F. Hertz; United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation -- Boston Field Division; Susan J. Waddell, Special Agent in Charge of Health and Human Services -- Office of Inspector General, Office of Investigations; Mark Dragonetti, Resident Agent in Charge of the Food and Drug Administration, Office of Investigations -- Office of Inspector General; and Jeffrey Hughes, Special Agent in Charge of the Northeast Field Office of the Veterans Affairs Office of the Inspector General, announced that the civil Complaint against Forest Laboratories Inc., of New York, New York, alleged that the company's illegal promotional practices surrounding its antidepressant drugs Celexa and Lexapro caused thousands of false and fraudulent claims to be submitted to federal health care programs.

The Complaint alleges that a double-blind, placebo-controlled, pediatric trial found Celexa no more effective than the placebo for pediatric use and that, in the study, more patients taking Celexa attempted suicide or reported suicidal thoughts than those in the group taking the placebo. The negative efficacy data led the FDA to deny Forest's request to approve Celexa for pediatric use. It is further alleged that, despite the FDA's denial of a pediatric indication, Forest actively promoted pediatric use of the drugs and misled physicians and the public by failing to disclose the results of the negative study. The same study was among those later considered by the FDA when it mandated that Forest add a "black box" warning to both the Celexa and Lexapro labels.

The Complaint alleges that Forest sought to induce physicians and others to prescribe Celexa and Lexapro by providing them with various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services, all in violation of the federal anti-kickback statute.

Neither Medicaid nor TRICARE ordinarily cover drugs for off-label uses unless the off-label use is for a medically accepted indication. The United States alleges that federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.

Prior to filing its Complaint, the government had intervened in two separate whistleblower actions against Forest that had been commenced under the qui tam provisions of the False Claims Act. The False Claims Act allows for private persons to file whistleblower suits to provide the government information about wrongdoing. Under the statute, if it is established that a person has submitted or caused others to submit false or fraudulent claims to the United States, the government can recover treble damages and $5,500 to $11,000 for each false or fraudulent claim filed. If the Government is successful in resolving or litigating its claims, a proper whistleblower can receive a share of between 15 percent and 25 percent of the amount recovered.

This investigation was conducted by the U.S. Attorney's Office for the District of Massachusetts, the Civil Division of the U.S. Department of Justice, the Federal Bureau of Investigation, the Office of Inspector General of the Department of Health and Human Services, the Office of Criminal Investigations of the Food and Drug Administration and the Office of Inspector General of the Department of Veteran's Affairs.


'/>"/>
SOURCE U.S. Department of Justice
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Coalition for Pulmonary Fibrosis Launches Aggressive Ad Campaign Directed at United States Congress
2. United States continues to have highest level of health spending
3. United Medicorp, Inc.s Shareholders Approve All Proposals
4. Proven Terumo Coronary Guidewire Technology Is Now Available in the United States
5. Medical Services International Received Its First Order for Testing By Regulatory Agencies in the United States
6. Peoples United Financial CEO Has Surgery
7. Statement by Mike Leavitt Secretary of Health and Human Services on the United States-China Bilateral Meetings on Food and Drug Safety
8. More Than 100 Organizations Call for a National AIDS Strategy to End the Epidemic in the United States
9. Akers Biosciences, Inc. ABI or the Company Receipt of Further United States Military Contracts
10. Universal Health Care Coverage in the United States
11. Women Deliver Conference to Feature United Nations Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... ... 2017 , ... The Radiology Business Management Association (RBMA) ... legislative activity and the latest regulatory concerns impacting RBMA members. The Legislative Education ... will continue through Monday, Sept. 11, at the Ritz-Carlton, Tysons Corner in Mclean, ...
(Date:5/26/2017)... ... May 26, 2017 , ... A new analysis of community ... healthiest seniors are located in the Midwest. With the average cost of healthcare rising ... are concerned with both the quality and affordability of where they live. An annual ...
(Date:5/26/2017)... BOSTON, MA (PRWEB) , ... May 26, 2017 , ... ... Care Act (AHCA), which narrowly passed the U.S. House on May 4, would result ... would be expected under continued implementation of the 2010 Patient Protection and Affordable Care ...
(Date:5/26/2017)... ... 26, 2017 , ... Silver Birch of Hammond, a new assisted lifestyle community, ... four acres of land at 5620 Sohl Avenue in Hammond, serves older adults who ... 125 studio and one-bedroom apartments. Each of the private apartments at Silver Birch features ...
(Date:5/26/2017)... ... May 26, 2017 , ... “When the Stars Lead ... is the creation of published author Laura Weigel Douglas, an avid reader who lives ... a house that sometimes feels like Green Hills Adventure Camp. She couldn’t be more ...
Breaking Medicine News(10 mins):
(Date:5/22/2017)... 2017  As the specialty pharmacy industry and ... make the revolutionary shift from volume-based to value-based ... positive patient outcomes and shaping the future of ... away from clinical trials and toward data that ... drug therapy utilization in precise patient populations. Therigy ...
(Date:5/15/2017)... PHILADELPHIA , May 15, 2017 Enterin Inc., ... and developing novel compounds to treat Parkinson,s disease ... The study is a Phase 1/2a randomized, controlled, multicenter study ... sites. It will enroll 50 patients over a 9-to-12-month period. ... doses in 10 patients with PD. Participating sites include ...
(Date:5/10/2017)... 10, 2017 Global Health Intelligence (GHI), ... America , published its 2017 ranking of the ... on extensive data analysis from GHI,s hospitals database for ... for the region. The GHI database covers 86% of the ... than 130 data points for each institution in key areas ...
Breaking Medicine Technology: